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What is the difference between Trisalus vs Marine Engineer?

AspectTrisalusMarine Engineer
Required CredentialsRelevant certifications in marine safety and engineeringEngineering degree, maritime certifications
Work EnvironmentShipboard or maritime industry settingsShip engines, marine vessels, or offshore platforms
Employer & Industry UsageMaritime companies, shipping linesShip operators, naval services, offshore firms
Common Search & ComparisonYesYes

Trisalus and Marine Engineer roles both involve marine safety and engineering skills, often requiring similar certifications. However, Trisalus typically focuses on specific safety systems and compliance, while Marine Engineers handle broader engine and vessel maintenance. Both roles are vital in maritime operations and often overlap in industry usage.

What are the key skills and qualifications needed to thrive as a professional at TriSalus Life Sciences?

To thrive at TriSalus Life Sciences, professionals typically need a background in life sciences, biotechnology, or related fields, often supported by relevant degrees or experience in medical device or pharmaceutical industries. Familiarity with clinical research tools, regulatory systems like FDA guidelines, and data analysis platforms such as SAS or R is highly valuable. Strong problem-solving abilities, collaboration, and adaptability are key soft skills for excelling in a dynamic, innovation-driven environment. These skills and qualifications drive successful development, regulatory approval, and delivery of advanced medical therapies.

What are some common challenges faced when working in a clinical or technical role at Trisalus, and how can new hires prepare for them?

At Trisalus, team members in clinical or technical roles often work with innovative medical devices and cutting-edge therapies, which can present unique challenges such as quickly adapting to new technologies, strict regulatory requirements, and cross-functional collaboration with clinical, R&D, and regulatory teams. New hires can prepare by staying current on industry trends, familiarizing themselves with FDA and other regulatory guidelines, and developing strong communication and teamwork skills. Active engagement in training programs and being open to feedback will help new employees overcome initial hurdles and thrive in this fast-paced, collaborative environment.

What is a Trisalus professional?

Trisalus professionals typically work for TriSalus Life Sciences, a company specializing in innovative drug delivery systems for the treatment of liver and pancreatic tumors. Their roles may involve research and development, clinical support, sales, or technical engineering of medical devices. These professionals collaborate with healthcare providers to improve cancer treatment outcomes by advancing targeted therapies and innovative infusion technologies. The work often requires a background in life sciences, engineering, or healthcare, and a passion for improving patient care through medical innovation.
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What job categories do people searching Trisalus jobs look for?

The top searched job categories for Trisalus jobs are:

Trisalus jobs near you
Infographic showing various Trisalus job openings in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% Physical job distribution.

Sr. Manufacturing/Process Engineer

Trisalus Life Sciences, Inc.

Westminster, CO • On-site

$115K - $125K/yr

Full-time

Re-posted 15 days ago

Job description

Duties and Responsibilities:

  • Lead the development, validation, and continuous improvement of manufacturing and process technologies for medical device products in accordance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
  • Serve as a senior technical resource for manufacturing and process engineering activities across multiple product lines.
  • Lead complex, cross-functional projects from concept through commercialization, including new product introductions, line extensions, and transfers from R&D to manufacturing.
  • Develop, qualify, and validate new manufacturing processes and equipment, including authorship and execution of IQ/OQ/PQ protocols, test method validations (TMV), and process validation reports.
  • Create and maintain the process validation master plan.
  • Apply statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA/Gage R&R), and process capability analysis to develop, characterize, troubleshoot, and control manufacturing processes.
  • Lead risk management activities for manufacturing processes, including authorship and review of PFMEAs.
  • Drive Design for Manufacturability (DFM) input during product development and design transfer activities.
  • Identify, evaluate, and implement opportunities to reduce cycle time, scrap, and manufacturing cost; develop and execute plans to capitalize on these opportunities.
  • Apply Lean manufacturing principles and continuous improvement methodologies to optimize production workflows, layouts, and equipment utilization.
  • Lead the evaluation, specification, design, and qualification of tools, fixtures, custom equipment, and production systems to meet capability and capacity requirements.
  • Monitor process output, yield, and scrap; analyze trends and drive corrective actions to improve performance.
  • Perform and oversee cleanroom (Class 8) validations as required.
  • Manage activities with outside vendors and contract manufacturers providing components, assemblies, processes, testing, and other services.
  • Lead investigations of nonconformances and support CAPA activities, including root cause analysis and effectiveness checks.
  • Author, review, and approve standard operating procedures, work instructions, engineering change orders, and related quality system documentation.
  • Train production operators and technicians on new processes and ensure adherence to process standards.
  • Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485.
  • May supervise and provide technical direction to engineers, technicians, and operators; mentor junior engineers and technicians.
  • Present project status, technical findings, and recommendations to cross-functional teams and management.
  • Maintain effective communications with supervisor, peers, and stakeholders.
  • Provide strategic direction for specific projects and contribute to departmental planning.
  • Support day-to-day manufacturing activities as needed.

Qualifications

Education & Certifications:

  • Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.

Work Experience:

  • Minimum of 10 years' experience in a medical device manufacturing environment is required.
  • FDA regulated work experience required.
  • Demonstrated experience leading process validations (IQ/OQ/PQ) and manufacturing process development require

Knowledge, Skills & Abilities:

  • Able to read, write and understand English.
  • Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485.
  • Proficiency in statistical methods including DOE, SPC, MSA, and process capability analysis.
  • Working knowledge of design controls, risk management, and CAPA processes.
  • Familiarity with Lean manufacturing and continuous improvement methodologies.
  • Strong project management and technical leadership skills.

Physical Requirements:

  • Able to work in both office and industrial/cleanroom environments